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      Multicentric and Observational Study of Omalizumab for Chronic Spontaneous Urticaria in Real-Life in Colombia

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          Abstract

          Background

          Although chronic urticaria (CU) is a common, cause of medical consulting both in general practitioners and allergist specialists worldwide, there is little information about its behavior and management in Latin America. Currently, national and international guidelines recommend using Omalizumab for cases refractory to management with antihistamines. Despite advances in the knowledge of Omalizumab for the management of CU, although there are few studies in underdeveloped countries, there are many studies evaluating the impact of Omalizumab treatment. There is not clinical information related with CSU-Omalizumab in patient settled in the Caribbean area. This research aims to evaluate the management of CU with Omalizumab in a real-life scenario in Colombia.

          Methodology

          We conducted an observational, descriptive, and retrospective study with patient recruitment between 2014 and 2017 of individuals diagnosed with Chronic Urticaria (CU) treating allergology specialists in five Colombian cities. We included patients with CU who failed to achieve disease control after treatment for 4 weeks with fourfold doses of second-generation H1-antihistamines, as recommended by the EAACI/GA 2LEN/EDF/WAO guidelines and who received treatment with Omalizumab.

          Results

          We included 123 patients, 73.1% ( n = 90) were women. The mean age was 47.1 years (Standard Deviation, SD: 16.2). The median of the total months of disease evolution was 30 (IQR = 13–58). 81.3 % ( n = 100) of patients were diagnosed with chronic spontaneous urticarial (CSU). 4.8% ( n = 6) had inducible CU (CIndU), and 13.8% ( n = 17) reported mixed urticaria (spontaneous CU with at least one inducible component). Regarding emotional factors, 34.9% ( n = 43) of subjects indicated anxiety symptoms, 34.1% ( n = 42) had exacerbations associated with stress, and 14.6% ( n = 18) manifested episodes of sadness. The percentage of patients with CSU controlled according to medical criteria at 3 months with Omalizumab were 80% ( n = 80/100) and at 6 months 87% ( n = 87/100). The frequency of adverse events was 29.2% ( n = 36), with headache being the most frequent adverse event.

          Conclusions

          This real-life study with Omalizumab at CU describes percentages of effectiveness and safety similar to those observed in pivotal and real-life studies conducted in other regions around the world.

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          Most cited references50

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          A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria.

          Proof-of-concept studies with omalizumab in patients with chronic idiopathic urticaria (CIU) have shown significant decreases in mean urticaria activity scores (UASs). We sought to evaluate the efficacy and safety of omalizumab in patients with CIU who remain symptomatic despite concomitant H(1)-antihistamine therapy. This phase II, prospective, double-blind, placebo-controlled, dose-ranging study investigated omalizumab in patients aged 12 to 75 years in the United States and 18 to 75 years in Germany with a UAS over 7 days (UAS7) of 12 or greater despite antihistamine therapy. Patients were randomized 1:1:1:1 to receive a single subcutaneous dose of 75, 300, or 600 mg of omalizumab or placebo added to a stable dose of H(1)-antihistamine. The primary efficacy outcome was change from baseline to week 4 in UAS7. Patients were followed for an additional 12 weeks to monitor safety. Ninety patients from the United States or Germany were enrolled. Both the 300-mg omalizumab group (-19.9 vs -6.9, P < .001) and the 600-mg omalizumab group (-14.6 vs -6.9, P = .047) showed greater improvement versus the placebo group in UAS7. No meaningful difference was observed for the 75-mg omalizumab group. Similar results were seen for key secondary end points of weekly hive and itch scores. Onset of effect occurred after 1 to 2 weeks. Omalizumab was well tolerated, and the incidence of adverse events was similar across treatment groups. This study demonstrated that a fixed dose of 300 or 600 mg of omalizumab provides rapid and effective treatment of CIU in patients who are symptomatic despite treatment with H(1)-antihistamines. Copyright © 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.
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            Autoimmune Theories of Chronic Spontaneous Urticaria

            Urticaria (hives) is a highly prevalent skin disorder that can occur with or without associated angioedema. Chronic spontaneous urticaria (CSU) is a condition which persists for more than 6 weeks in duration and occurs in the absence of an identifiable provoking factor. CSU results from pathogenic activation of mast cells and basophils, which gives rise to the release of proinflammatory mediators that support the generation of urticaria. Several theories have been put forth regarding the pathogenesis of CSU with much evidence pointing toward a potential autoimmune etiology in up to 50% of patients with this condition. In this review, we highlight the evidence surrounding the autoimmune pathogenesis of chronic urticaria including recent data which suggests that CSU may involve contributions from both immunoglobin G (IgG)-specific and immunoglobulin E (IgE)-specific autoantibodies against a vast array of antigens that can span beyond those found on the surface of mast cells and basophils.
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              The clinical response to omalizumab in chronic spontaneous urticaria patients is linked to and predicted by IgE levels and their change

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                Author and article information

                Contributors
                Journal
                Front Allergy
                Front Allergy
                Front. Allergy
                Frontiers in Allergy
                Frontiers Media S.A.
                2673-6101
                2673-6101
                20 May 2022
                2022
                : 3
                : 902344
                Affiliations
                [1] 1Departamento de Alergología, Fundación Santa Fé de Bogotá , Bogotá, Colombia
                [2] 2Facultad de Medicina, Universidad de los Andes , Bogotá, Colombia
                [3] 3Departamento de Alergología, Unidad Médico Quirúrgica de Otorrinolaringología (UNIMEQ-ORL) , Bogotá, Colombia
                [4] 4Servicio de Alergología, Clínica de alergias de Colombia , Ibagué, Colombia
                [5] 5Departamento de Medicina, Universidad del Norte , Barranquilla, Colombia
                [6] 6Centro de Alergia e Inmunología Sarrazola, Clínica San José de Cúcuta , Cúcuta, Colombia
                [7] 7IPS Universitaria, Universidad de Antioquia , Medellín, Colombia
                [8] 8Unidad de Alergia, Fundación Valle de Lili , Cali, Colombia
                [9] 9Facultad Ciencias de la salud, Universidad ICESI , Cali, Colombia
                Author notes

                Edited by: Nicola Wagner, University of Erlangen Nuremberg, Germany

                Reviewed by: Gianfranco Calogiuri, Ospedale Vito Fazzi, Italy; Mona Al-Ahmad, Kuwait University, Kuwait

                This article was submitted to Skin Allergy, a section of the journal Frontiers in Allergy

                †These authors have contributed equally to this work

                Article
                10.3389/falgy.2022.902344
                9234875
                23fe31cc-d976-432c-aae5-23875ea43c91
                Copyright © 2022 García-Gómez, Chapman, García-Paba, Ocampo-Gómez, Egea-Bermejo, Garavito-De Egea, Fang, Sarrazola, Sánchez-Caraballo, Serrano-Reyes, Silva-Espinosa, Rojas-Mejía and Moreno.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 23 March 2022
                : 03 May 2022
                Page count
                Figures: 1, Tables: 4, Equations: 0, References: 50, Pages: 8, Words: 5946
                Categories
                Allergy
                Original Research

                urticaria,angioedema,omalizumab,inducible,antihistamines
                urticaria, angioedema, omalizumab, inducible, antihistamines

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